Search by Drug Name or NDC

NDC 17714-0045-30 Pepto Relief 262 mg/1 Details

Pepto Relief 262 mg/1

Pepto Relief is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Advance Pharmaceutical Inc.. The primary component is BISMUTH SUBSALICYLATE.

MedlinePlus Drug Summary

Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Related Packages: 17714-0045-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	17714-0045
Product ID	17714-045_60f4322f-5cb1-096a-e053-2a91aa0a64eb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Pepto Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	262
Active Ingredient Units	mg/1
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	Advance Pharmaceutical Inc.
Pharmaceutical Class	Bismuth [CS], Bismuth [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17714-0045-30 (17714004530)

Pricing Information	N/A
NDC Package Code	17714-045-30
Billing NDC	17714004530
Package	30 TABLET, CHEWABLE in 1 BOTTLE (17714-045-30)
Marketing Start Date	2002-01-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a02babe7-9255-44c7-90e1-b5ad5e59c72a Details

Drug Facts

Active Ingredient

(in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Anti-diarrheal/Upset stomach reliever

Uses

Controls diarrhea
Relieves upset stomach due to overindulgence in food or drink

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products
Do not use
If you have bloody or black stool
If you have an ulcer or bleeding problem
Ask a doctor before use if you have
Fever
Mucus in the stool
Ask a doctor or pharmacist before use if you are
taking any drug for
anticoagulation (thinning the blood)
diabetes
gout
arthritis
when using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

stop use and ask a doctor if
symptoms get worse
ringing in the ears or loss of hearing occurs

diarrhea lasts more than 2 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
repeat dosage every 1/2 to 1 hour as needed
do not take more than 8 doses in 24 hours
use until diarrhea stops but not more than 2 days
adults and children 12 years and over: 2 tablets
children under 12 years: ask a doctor

Other Information

Each tablet contains: calcium 77 mg, salicylate 102 mg
store at 15°-30°C (59°-86°F)
protect from moisture

INACTIVE INGREDIENT

calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday

Package Label

NDC: 17714-045-30 – 30 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

PEPTO RELIEF

bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17714-045
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTROSE (UNII: IY9XDZ35W2)
CHERRY (UNII: BUC5I9595W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	pink (light)	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	AP;045
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:17714-045-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2002

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	01/09/2002

Labeler - Advance Pharmaceutical Inc. (078301063)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(17714-045)

Revised: 12/2017

Document Id: 60f4322f-5cb1-096a-e053-2a91aa0a64eb

Set id: a02babe7-9255-44c7-90e1-b5ad5e59c72a

Version: 2

Effective Time: 20171222